Adamson Analytical Laboratories, Inc.Product: finished pharmaceuticals Date: 8/2/2016 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API). Your firm failed to exercise appropriate controls over computer or related systems to assure that...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.